Syringe, 3cc

GUDID 00850007350048

Syringe, 3cc, sodium chloride injection USP 0.9% (10/pkg)

C2DX, INC.

Compartmental-pressure monitoring system, single-use

• Primary Device ID: 00850007350048
• NIH Device Record Key: 9cea9f38-7e88-4625-9059-0a95502caaa8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Syringe, 3cc
• Version Model Number: 0295-005-000
• Company DUNS: 116981210
• Company Name: C2DX, INC.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com
• Phone: 888-902-2239
• Email: c2dx@c2dxinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850007350048 [Unit of Use]
GS1	10850007350045 [Primary]
GS1	30850007350049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K844214

FDA Product Code

• LXC: Monitor, Pressure, Intracompartmental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-16
• Device Publish Date: 2020-04-08

Devices Manufactured by C2DX, INC.

• 00850007350321 - Wire Guide: 2026-02-18
• 00850007350338 - Salivary Access Dilator Set: 2026-02-18
• 00850007350345 - Kolenda Salivary Introducer Set - 5.0: 2026-02-18
• 00850007350352 - Kolenda Salivary Introducer Set - 6.0: 2026-02-18
• 00850007350369 - NGage Salivary Stone Extractor: 2026-02-18
• 00850007350376 - NCircle Tipless Salivary Stone Extractor: 2026-02-18
• 00850007350383 - Sialocath Salivary Duct Catheter: 2026-02-18
• 00850007350390 - Advance Salivary Duct Balloon Catheter Set - 1.5: 2026-02-18